JP3220456B2 - New inhaler - Google Patents

Abstract

An inhaler for powdered medicament in capsules has a swirling chamber which can be opened to allow access of a closed capsule into the swirling chamber for operation of capsule-opening means in the swirling chamber. Access to the swirling chamber is gained by a pivoting cover member (22) which is provided with interlock means associated with the capsule-opening means to ensure that the capsule opening means cannot be operated while the cover member is in its open position to allow access of the user's fingers to the region (28) of the swirling chamber (26,28) where the capsule-opening pins (30) could damage the user's finger. <IMAGE>

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an inhaler which allows a patient to inhale a powdered medicament from a capsule.

Various forms of inhaler are already known and are known to provide a means for piercing the end of the capsule so that the medicament can be inhaled during inhalation.

The drug can be extracted by spinning the capsule by the inhalation airflow passing through the capsule, ie, by the vortex form of the airflow passing through the inhaler. The spin of the capsule assists the ejection of the powdered drug in the capsule that repeatedly collides, and feeds the drug into the inhalation airflow.

The means for piercing the drug capsule is known to be a pin, which can be configured to move the pin inward from the end of the capsule and puncture the capsule with the sharp tip of the aperture pin. . Disadvantages of known inhalers of the type that pierces the capsule include, for example, the use of the inhaler by a child or the accidental misuse of the patient, causing the finger of a person to stick when operating the capsule opening pin. There is something that can happen.

The chamber of the device is usually opened to allow for the insertion of unused capsules, and the capsules are also ensured that the opened capsules are enclosed in the chamber between the opening operation of the capsules and the suction agitation. Since the piercing pin can be used in the chamber, it is possible to gain access to the chamber, which allows the finger to fully enter the space normally occupied by the pierced capsule, thus causing injury.

It is an object of the present invention to prevent any inadvertent or intentional misuse that could lead to finger injury in the chamber of the inhaler.

Therefore, the present invention is an inhaler for inhaling a powdered drug from a capsule opened in an inhaler, and rotating the opened capsule in a suction gas flow flowing through a vortex stirring chamber. A vortex agitating chamber for holding the capsule for extracting the powdered drug, means in the vortex agitating chamber for opening the capsule inserted in the vortex agitating chamber for inhalation, and vortex agitation. A closing member movable between a first position for closing the chamber and a second position allowing access to the vortexing chamber for insertion of the capsule, and a second member for inhibiting operation of the capsule opening means. An interlock means responsive to positioning the closure member in the position of, wherein the chamber is non-circular and elongate about the transverse axis of the capsule under the influence of suction airflow. Allowing the capsule to rotate, increasing the likelihood of injection of the medicament from within the capsule by causing the capsule to collide with at least one further wall, wherein the capsule opening means dissolves the powdered medicament during vortexing. Providing at least one pin axially drivable in the elongate capsule in a vortexing chamber for piercing the capsule to provide a releasable aperture at the end of the capsule. Provide an inhaler.

In order to make the invention easier to understand, the following description is given by way of example only with reference to the following accompanying drawings.

FIG. 1 is a vertical side view of the inhaler of the present invention, showing the mouthpiece cover in cross-section for easy viewing of the mouthpiece itself.

FIG. 2 is an elevation view taken along the direction of arrow II in FIG.

FIG. 3 is a cross-sectional view showing the position of the capsule opening pin on the right side during the operation of bursting the capsule, and the left side showing the state in which the capsule opening pin is stored.

FIG. 4 is an elevational view of a removable capsule container used in the apparatus of FIGS.

 FIG. 5 is a sectional view taken along line VV in FIG.

FIG. 6 shows an improved detail of an inhaler assembled with a locking mount.

FIG. 1 shows the inhaler 2 consisting of a body 4 with a mouthpiece 6 closed by a friction-fitting cover 8 on the body of the inhaler.

U-shaped springs along each side of the inhaler body 4
There are ten limbs, and the user's thumb and other fingers are positioned in the arcuate recess 12 also shown in FIGS. 2 and 3 and pressure is applied between them to remove the rim from the rest. It is designed to be pressed against the rim.

FIG. 1 also shows, at the top of the body 4, an inlet 14 which constitutes one of the two inlets leading to the vortex agitating chamber, with which the open capsule is swirled, spun, The capsule is made to collide with the wall of the chamber, and the powdered drug is ejected from the inside of the capsule.
To enhance the vortexing action of the capsule, the chamber has opposing upper and lower walls (see FIGS. 5 and 6), which are generally flat cylindrical and whose axial dimension is smaller than the diameter of the capsule. Large and less than the length of the capsule, while the diameter of the chamber is greater than the length of the capsule. A capsule form conventionally used for storing a powdered drug is composed of a capsule body and a capsule cap, which is fitted so that the capsule cap covers the capsule body, and has a hemispherical end. The columnar form is the final shape of the capsule. By the "diameter" of the capsule we mean the diameter of the center of the cylinder,
By the "length" of the capsule is meant the total length of the column and the two dome-shaped ends.

The front vertical view shown in FIG. 2 as viewed along the direction of arrow II in FIG. 1 shows the exposed portion of the rim of the U-shaped spring 10 that can be seen in the bow 12 of the body 4.

FIG. 2 also shows a sliding cover 16 of the capsule container which can be removed as needed, which will be described in detail later with reference to FIGS. Sliding the cover 16 downward from the position shown in FIG. 2 retracts the top end 18 of the lid, exposing one end within the capsule container to release the capsule from the normally closed container.

FIG. 2 also shows a screen grid 20 on the wall of the chamber closer to the mouthpiece 6 to prevent debris of the capsule from entering the mouthpiece and therefore into the respiratory tract of the patient, at a partial cut-out of the inhaler. Is shown. Screen 20 is also shown in FIG.

FIG. 2 also shows a cover 22 that can be opened by pivoting about a hinge line 24 to expose the interior of the vortexing chamber. The chamber includes the cylindrical portion 26 having a recess 28 positioned adjacent to hold a capsule opened in the chamber. The aperture mechanism will be described later with reference to FIG. 3, but it is important to note that the present invention provides for the preferred positioning of the capsule aperture means, which is a pair of aperture pins operating in chambers 26,28. However, there is no need to insert the capsule into the vortex stirring chamber with the end of the capsule opened.

As mentioned above, in the relaxed state, the rim of the spring 10 is visible in the arcuate recess 12 and FIG. 2 shows that both limbs of the spring are substantially flush with the right end of the body 4. Show.

FIG. 3 shows the left rim of the spring 10 in this position, but the right rim 10 is pushed inward,
Capsule opening pin 32 that moves when 10 rims are pressed
Is moved inside the chamber recess 28 and pierces the capsule, shown in phantom. The chain line shown on the left side of FIG. 3 is also the tip of the capsule opening pin on the opposite side at the capsule opening position.

As shown by the dashed line on the left side of FIG. 3, the capsule piercing pin 32 is generally L-shaped and has an element 34 shown in dashed line and embedded in the rim of the spring, while substantially The right-angle bend and the other rim of the spring protrude into the recess 28 of the chamber. During the capsule opening movement of the pin, in particular, it must be kept in mind that when the two pins begin to push on the dome-shaped end of the capsule, the sharp tip 30 of the pin is moved to the hemispherical dome-shaped end of the capsule. In this case, the two capsule opening pins are moved to the respective positioning portions 36 to guide the pins.
Guided by This positioning portion 36 is located as close as possible to the position of the capsule in the recess 38 in order to center the pin 32 reliably when piercing the capsule.

The right side of FIG. 3 shows a state in which the stud 38 formed integrally with the rim of the spring 10 has moved through the hole 50 into the body of the inhaler. On the other hand, the stud 38 of the rim on the left side of the spring is remote from the space between the two walls 40 of the inhaler body 4, the tip of which is retracted in the hole 50.

The purpose of these two studs 38 is to interlock between the rim of the spring 10 and the cover 22 which can be opened to allow access to the vortex chamber to load the capsule into the recess of the vortex chamber for opening. Is to provide.

As shown in FIG. 5, the upper end portion 44 of the cover is raised from the adjacent surface of the inhaler main body, so that the user can hook a thumb or a fingernail behind the upper end portion 44 and partly by the chain line in FIG. The cover 22 can be pulled to the open or "second" position 22 'shown.

Additional semi-circular ears 48 on cover 22 are also shown in dashed lines and as shown in solid lines in that position occupied when cover 22 is closed, ie, in the "first" position. There is a hole 46. Each side of the cover has such separate ears 48, each provided with a hole 46, which is only open when the cover 22 is in the closed position shown in solid lines in FIG. It is adapted to be aligned with a similar hole 50 in the part 40. The pivot cast iron 52 shown by a chain line in FIG.
With the rotatable cover 22 in the other position (FIG. 2), the ears 48 are adjacent to and sandwiched by the walls 40,
The hole 50 is closed, thereby preventing the rim of the U-shaped spring 10 from being pushed into the position shown on the right in FIG.
Because of this, the studs 38 cannot approach each other,
Consequently, the sharp tip 30 of the capsule opening pin 32 is also in the position shown on the left side of FIG. 3, that is, completely retracted into the positioning portion 36 where there is no danger of inadvertently piercing the user's finger.

Eliminate holes 46 that are selectively provided and cover ears 48
Other configurations are possible that allow operation of the capsule opening pin at a position other than when the is completely closed. However, the preferred arrangement of FIG. 5 in which an additional hole 50 is provided and the hole 50 is closed at all other times than when the cover 22 is fully seated is considered to be the safest.

The danger of such a user's finger stab is not only due to the intentional misuse of the device by a child or accidental misuse of the device by an adult or child, but also by the previous inhaler lump. It can also occur by normal scanning of the device for removing powdered drug from the vortexing chambers 26,28. Given the need to clean the device, it is advantageous to have an interlock that prevents the capsule aperture pin from coming out of the recess 28 while access to the chamber is possible.

The configuration of the vortexing chamber with the generally cylindrical portion 26 and the generally adjacent capsule holding recess 28 in which the capsule opening means operates is described in our co-pending UK Patent Application No. 901326.
1.4, wherein (1) the centrifugal ejection of the contents by a vortexing action of the vortex suction airflow that drags the capsule to rotate or spin the capsule in the chamber, and (2) the end of the capsule It is considered to be very effective to cause the ejection by hitting when hitting the non-circular chamber side wall, particularly the obtuse corner between the concave portion 28 and the substantially cylindrical chamber portion 26. Further, the above-mentioned UK Patent Application No. 9
013261.4 states that the capsule is always kept in the same plane (center plane of the chamber) due to the roughly flat shape of the chamber, thereby improving the strength and control of the rotational collision operation of the capsule and injecting the powdered drug by centrifugal force. Says.

FIG. 3 shows two vents to the vortex stir chamber, one of which connects internally from the inlet 14 also shown in FIG. 1 and is generally open at port 54 to the generally cylindrical chamber 26, from which Airflow enters and impacts the capsule (shown in dashed lines in FIG. 3) causing the capsule (note that the two pin tips 30 have now retreated into the positioning portion 36) from the capsule rupture recess 28. Helps to extrude, thereby releasing the capsule so that it is entrained in the vortex in chamber 26.

The remaining intake port 56 communicates with a passage leading to the port 58, and the port 58 transfers the inhaled air to the port 54 described above.
Emitting along a direction that is not parallel to the direction of the air from.

As shown in FIG. 3, the bent portion 60 of the U-shaped spring 10 is fixed to the main body 4 of the suction member by a hollow stud 62 also shown in FIG. In practice, the body part 4 comprises a front part 64 in which the mouthpiece 6 is formed and a rear part 66 connected to the front part 64.
In this case, these two parts 64, 66 are joined by ultrasonic welding at their interengaging parts.

Alternatively, the two parts 64, 66 of the inhaler body 4 can be fixed together by locking engagement means providing a snap-fit which facilitates the assembly of the inhaler body, details of the variant. 6 is shown in FIG. 6, where the parts shown in FIG. 5 are given the same reference numerals and the locking arrangement 68 is also shown.

The grid screen 20 can of course be embedded in the chamber component 72 during the manufacturing stage, and there are still other methods. For example, a grid can be insert molded into a storage ring and the ring inserted into the mouthpiece.

The chamber 72 is made of a polymer having a small surface resistance so as to minimize the degree to which the released powder medicine adheres to the surface of the air passage in the inhaler, thereby providing an antistatic property. The material constituting the inner walls of the chambers 26 and 28 is preferably a polymer having a surface resistance of preferably 10 ¹² Ω, more preferably less than 10 ⁸ Ω. In this embodiment, the entire chamber constituting the main body 72 is formed of the same polymer having the same low surface resistance. However, if desired, the chamber may be formed by lining a low surface resistance material.

The term "antistatic material" is intended herein to refer to a material that does not readily exert an electrostatic attraction on the powdered drug released from the opened capsule into the inhaler. The antistatic property has a high electrostatic dissipative property on the surface,
And / or having high electrical conductivity; and / or
Alternatively, it is provided by having a low surface resistance.

Numerous additives are known that improve the antistatic performance of polymers by, for example, improving electrical conductivity, reducing surface resistance, or enhancing electrostatic dissipative. One possible method is carbon or iron filler (often in fiber form)
Is incorporated into the polymers used to make these parts to provide antistatic performance. Alternatively, non-fibrous chemical materials can often be incorporated into the molding polymer in chip form prior to the molding process and used to reduce the surface resistance of the molded article. Product P manufactured by Atochem in France
ebax is a polyester block amide product, which provides antistatic properties through the use of such additives.

Another possibility is to coat the molding with an electrically conductive layer, thereby reducing the surface resistance.

Surface resistance is preferably 10 ¹² Ω, more preferably 10 ⁸ Ω
Less than is desirable.

Still more preferably, the mouthpiece 6 has an inner wall made of such a material and the cover 22 closing the back of the vortexing chamber is made of such a polymer having a low surface resistance. preferable.

FIG. 5 shows an optionally removable capsule storage box comprising a lid 74 hinged to the box via a box 74 and a thin film hinge 78. This box has the sliding cover 16 described above, between the bottom surface 82 of the box and the engaging surface of the front body 64 of the inhaler,
Also, the upper end surface 184 of the dome-shaped portion 186 of the lid 76 and the abutting end of the recess of the inhaler front main body portion 64 that receives the dome-shaped cover portion 186 are held in place in the device by frictional contact. Is done.

The intent of removing the capsule containers 74, 76 is to remove the containers and keep them dry while cleaning the rest of the device and removing the build-up of sticking powdered medicament from the walls of the inhaler's vent. . In this way, the containers 74, 76 are never exposed to the powdered medicament (because the capsules contained in the containers are always closed) and these inhalers require cleaning to remove the stuck medicament. Can be placed separately from the part. The container can then be reinserted when the cleaned portion of the device has completely dried and is ready for the next use.

Another benefit of being able to remove the container is that it allows the pharmacist to prepare a package pre-loaded with capsules in the container and simply plug it in instead of a disposable or reusable empty container. Is possible.

When the containers 74 and 76 are reused, refilling of the capsule is performed by first removing the containers 74 and 76 from the other part of the inhaler 2, opening the lid 76, and exposing the inside, that is, the container 74. Will be In the unlikely event that the capsule is inadvertently wetted, the gelatin body of the capsule becomes soft and sticky, such a capsule can be easily removed by opening the lid 76.

Then insert a new refill of the capsule into box 74 and cover 76
Is closed and the container is inserted again into the inhaler 2.

As described above, the sliding cover 16 is a part of the container,
It is possible to pull down to release the top capsule shown at C in FIG. To this end, the sliding cover 16 has a shoe 84 sized to be received in a slot 86 in the box 74. The shoe 84 can also be pushed past the slot 86, but has an end 88 that is too wide to return to the slot 86, so that the slide 16 does not come off the box 74.

The sliding cover 16 is further provided with a detent shoe 90, which engages on the bar 92 of the box 74 at the top of the slide, when the shoe 90 rides on the bar 92. Only when the sliding cover 16 is strongly pulled down so as to bend the sliding portion, it is possible to cross the bar 92 only. When the sliding portion is returned to the upper side again, a similar locking operation for holding the sliding cover is performed at the uppermost portion. The upper and lower ends of the detent shoe 90 are chamfered so that the shoe 90 can easily pass in any direction of the bar 92.

The alternative configuration shown in FIG. 6 merely illustrates another method of assembling the inhaler, and is by no means intended to remove the lock 68 during the life of the inhaler. . Providing these locking portions is merely intended to facilitate the assembling operation of the inhaler after molding.

In FIG. 6, the grid 20 is inserted into the mount ring 70, and the mouthpiece 6 is provided integrally with the vortex stirring chamber component. This integral member 6 is injection molded from a suitable antistatic polymer material.

The assembling operation of the inhaler 2 shown in the figure is performed as follows.

The grid 20 already inserted and molded into the mount ring 70 (FIG. 6) is first snap-fixed to a predetermined location (when the grid is not embedded in the chamber component 72 as shown in FIG. 5, or a mouthpiece).

The two holders for the aperture pins 32 are slid into place in the chamber as shown in FIG. The integral mouthpiece and the chamber member 6 are inserted into the front cover 64.

 Insert the pins 32 and 34 into the spring 10.

Next, the U-shaped spring 10 and the front main body 64 of the inhaler main body are fixed by inserting the hollow stud 62 of the front main body 64 into a socket provided at the bent portion of the spring 10. As shown on the left side of FIG. 3, when the spring is in the open position, the cover 22 is snap-fixed in place, and at the same time, the pivot casting bar 52 of the ear portion 48 is inserted between the two wall portions 40. Snap into place at the hole 53 formed to receive the.

Next, when the cover 22 is in the closed position, the rear body portion 66 is aligned with the other attachment portions, and the joining portion between the two members 66 and the remaining attachment portions is joined by ultrasonic welding. Alternatively, the member 66 is pushed into the remaining mounting portion and locked. At this time, by deforming the leg 96, the locking portion 68 rides on a corresponding rib such as 94 in FIG. 6, and the locking portion 68 is positioned on this leg.

Finally, the mouthpiece cover 8 is snap-fixed to a predetermined position, and the capsule containers 74 and 76 are attached to the predetermined positions. Of course, assembling the sliding cover 16 to the box 74 simply exerts a strong pressure on the box 74 (i.e., to the right in FIG. 5) and the detent edge of the blade 84 through the slot 86. It is also possible to do this by moving 88.

In the above description, the mesh screen 20 has been described as a stainless steel mesh having an advantage of being electrically conductive. However, if necessary, a suitable screen having electrical conductivity or electrostatic dissipative property, or having a low surface resistance may be used. Any other material can be used as long as it is an antistatic material, is non-corrosive, and has resistance to washing. For example, it is also possible to integrally mold the mesh as a part member together with the remaining part of the chamber constituting portion 72.

All components of the inhaler can be formed by injection molding and, as will be seen, the only complication is the embedding of the L-shaped pins 32, 34 at the ends of the rim of the spring 10. All that is necessary and to embed the mesh 20 in the chamber component 72.

Independent holding part 36 for supporting capsule opening pin 32
The purpose of having is to form a passage for the pin 32 along a direction converging in the direction of the air passage between the inlet 14 and the port 54 on the right side of FIG. This is to eliminate the need to do so. The retainer will also serve as an additional seal to prevent air from entering the suction chamber and powder loss therefrom.

 The use of the device shown in the figure is described below.

Typically, the device is stored in a storage box or pocket, or handbag, with the mouthpiece cover 8 attached and the capsules stored in removable containers 74,76. If inhalation is required, the user can apply pressure on the thumb grip rib shown in FIG.
4. Shift the cover 16 off of the 76 to expose the slot normally occupied by the beveled blade 90 of the sliding cover 16. This operation is best done with the device upside down, so that when the sliding cover 16 is fully opened, the capsule shown in FIG. 5C is easily accessible through the slot.

After taking out one capsule C, the sliding cover 16 is returned to the position shown in FIG. 5, the containers 74 and 76 are closed, and the cover 22 is hooked on the end of the fingernail or the thumb on the upper end 44, and the cover 4 is removed from the main body 4 (FIG. 5) Open by pulling out the top of cover 22)
Alternatively, the cover 22 is released by applying pressure downward to the lowermost end thereof. (This latter movement can stress the hinged casting beso 52 and is not the easiest way to open the cover 22.) Next, the capsule C is opened by the sharp tip 30 of the pin 32. It is manually placed in the capsule opening recess 28 (FIG. 3). The capsule is shown in phantom lines in FIGS.

Next, the cover 22 is closed again, snapped and closed. As a result, the hole 46 of the ear portion 48 is aligned with the stud 38 of the spring 10, and it is possible to operate the capsule opening mechanism for the first time. At this stage, the mouthpiece cover 8 is detached and exposed for inhalation.

The user pushes the exposed part of the rim recess 12 (FIG. 2) of the U-shaped spring 10 and pushes the pin 32 guided by the positioning part 36 into the end of the capsule. Capsule opening operation releases the rim of spring 10,
The process ends by returning to the position of FIG. 2 (the left-hand side of FIG. 3).

At this point, the user places his or her lips on the mouthpiece and inhales, thereby inhaling airflow from each of the inlets 14, 56 (FIG. 3), and the chambers 26 through ports 54, 58 (FIG. 3). , Lead to 28. This air flow creates a vortex in the circular region 26 of the chamber, lifting the capsule from the position shown in FIG. 3 of the recess 28 and striking it at high speed by spinning rotation. During this spin, the horizontal axis of the capsule substantially coincides with the axis of symmetry of the cylindrical portion 26 of the chamber. Two ports 54
And 58 and the fact that they are not parallel to each other, and that the capsule aperture recess 28 is in contact with the cylindrical chamber 26, the walls of the chambers 26, 28 during rotation of the capsule The capsule collides with
Thus, the powdered drug in the capsule is ejected from both ends of the capsule where the holes are formed. This injection is due to the centrifugal motion due to the spin of the capsule and to the impact on the wall, in particular on the corner of the chamber wall between the capsule-shaped recess 28 and the rest of the generally cylindrical shape 26 of the vortexing chamber. Occurs as

During the opening operation, if the end of the capsule breaks and fragile debris is scattered, these debris will not enter the user's respiratory tract. This is because the inhaled air from the vortexing chamber and the powdered drug carried by it must pass through the screen 20 before entering the mouthpiece 6. This screen 20 captures any debris of the capsule, ensures that the body of the capsule is captured, and prevents the user from swallowing.

The device according to the invention is able to address this problem satisfactorily even when the capsule is broken. This is because when piercing and inhaling the capsule, the capsule is held in a vortex agitating chamber behind the screen 20, whereas in devices such as EPA 0 333 334, the capsule is removed before closing the chamber. Since the holes are pierced by pressing against the pins fixed therein, crushing of the capsule cap or capsule body leads to a loss of the drug, thereby causing a problem of insufficient dosage. This device opens both ends of the capsule at the same time, but in this conventional device, it is necessary to open both ends of the capsule separately, which further complicates the problem.

It is desirable that all drug powder reach the user's respiratory tract, and indeed, the device according to the invention achieves a high removal rate of powdered drug from the capsule and, overall, a high efficiency of drug removal from the inhaler. To achieve, while minimizing the pressure drop in the inhaler. The low pressure drop in the device is particularly important. Because the main purpose of the device is the administration of a medicament to bring about a therapeutic effect on the patient's respiratory tract, such a patient's respiratory tract is already quite weak and cannot generate large pressure differences Because.

For example, with a suction volume of 60 liters per minute, the device removes powder from the capsule shell with 98% efficiency and
A pressure drop of 26.9 cm was measured, and at 30 liters per minute, the efficiency of emptying the capsule dropped to only 93% and the pressure drop dropped to 6.9 cm at the water level. The pressure drop at 40 liters per minute is 12.8 cm at the water level,
At 50 liters per minute, the water level is 18.8 cm, and at 20 liters per minute, the water level is 2.8 cm. 60 liters per minute to 3 per minute
Of particular significance is the fact that lowering the suction flow rate to 0 liters results in only a slight decrease in the efficiency of emptying the capsule. This means that a patient already having a serious impairment in respiratory function can efficiently inhale all the available drugs in the capsule with a single inhalation.

By comparison, the apparatus was tested at the same flow rate, but without the capsule in the vortexing chamber, and the pressure drop in the apparatus was as shown in Table 1. Table 1 Flow rate (liters / minute) 20 30 40 60 Pressure drop (cm water level) 3.4 8.0 14.9 32.9 Surprisingly, when there is a capsule, the pressure drop is actually less, which can further aid the inhalation by the patient.

Due to the low surface electrical resistance of the material chosen appropriately for the inner wall of the vortex chamber of the inhaler, and possibly also for the mouthpiece, the drug powder that remains on these walls and accumulates and sticks with the residues from subsequent use Minimize the amount of

However, from time to time it may be effective to clean the vent, in the illustrated device first take the capsule containers 74, 76, if possible, and then thoroughly clean and then dry the device. . Once the device is completely dry,
Re-insert 74, 76 and reattach mouthpiece cover 8 to prepare for storage and next aspiration.
Washing and drying operations of the vortex stir chamber and mouthpiece are performed by rotating the cover to reach the inside of the vortex stir chamber.
It will of course be understood that this is accomplished by opening 22 from the back of the inhaler.

The device according to the invention has the further advantage that the efficiency measurement of the release of the medicament powder from within the capsule can be easily reproduced for a particular applicable inspiratory rate.

In addition, due to the collisions that occur with the design of the chamber, the generation of turbulence and the centrifugal component of capsule motion, the performance of the device is very consistent over a wide range of inhalation rates. Table 2 shows the performance of the device.

Performance evaluation was performed using an existing two-stage impinger (1988, apparatus A described in British Pharmacopoeia, pages A204-A207 (Appendix 17C)). This device indicates the amount of drug that will reach the bronchioles and alveoli of the person using the inhaler by the amount of powder reaching the second stage of the impinger.

 Salbutamol sulfide was used as the test drug.

The delivery of the drug to the lungs and its reproducibility are very good,
Better than comparable market products. Table 2 Inhaler performance using a BP two stage impinger (Apparatus A) (a) Percentage of medication reaching the second stage of the impinger Gas flow (liters / min) (%) 20 22.1 30 28.5 60 25.9 (b) Reproducibility of dosing: Six consecutive capsule impacts. The results are shown as relative standard deviation (%).

Gas flow rate (l / min) (%) 20 13.8 30 4.3 60 5.4 Capsule before operating the capsule opening pin by pushing on the spring 10 without imposing any skill or practice on the part of the operator when using the device. If the patient confirms that he is in the correct position, the capsule will always open at both ends and will always release the contents at a very fast rate even at low inhalation rates.

In the embodiment of FIGS. 1-5, the mouthpiece 6 may be integrated with the chamber component 72, as shown in FIG. 6, and in this case there is no separation line where the drug powder may be bulky, which is practically convenient. is there.

Cleaning can be carried out by either wiping or washing, but dry cleaning is preferred because residual moisture causes more inconvenience than that caused by static electricity in the mouthpiece and chamber.

──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Hobbs, Michael Anthony Essex S.A.R.M. 107 D.E.S.S.Digienham Raynham Road South (no address), Lorne-Poolan Lorremitted (72) Inventor Leighton, Ann-Marie Essex, UK 107 Essex S. Digienham, Ranham Road South (no address), Lorne-Poullan Lorelli Limited (72) Inventor Simpkin, Gordon Thomas Essex S.E.M.・ Digienham Raynham Road South (no address) ・ Lorne-Phulan Lorelli Limited (72) Inventor Tranley, B B. Essex, R.E.M. 107 E.S.S.S.D.S.Digienham Leinham Road South (no address), in Lorne-Poulenc-Lorremitique (56) References JP-A-60-185564 (JP, A) European Patent Application Publication 406893 (EP, A1) (58) Field surveyed (Int. Cl. ⁷ , DB name) A61M 13/00

Claims (6)

(57) [Claims] An inhaler for inhaling a powdered drug from a capsule opened in an inhaler, wherein the opened capsule is rotated in a suction gas flow flowing through a vortex stirring chamber. A vortex mixing chamber for holding the capsule for extracting the powdered drug, means in the vortex mixing chamber for opening the capsule inserted in the vortex mixing chamber for inhalation, and a vortex mixing chamber A closing member movable between a first position for closing the capsule and a second position allowing access to the vortex agitating chamber for insertion of the capsule, and a second member for inhibiting operation of the capsule opening means. An interlock means responsive to positioning the closure member in a position, wherein the chamber is non-circular and the capsule is elongated about the transverse axis of the capsule under the influence of the suction airflow. To increase the possibility of injection of the medicament from within the capsule by impinging the capsule against at least one further wall, wherein the capsule opening means dissolves the powdered medicament during vortexing. Providing at least one pin axially drivable in the elongate capsule in a vortexing chamber for piercing the capsule to provide a releasable aperture at the end of the capsule. Inhaler. 2. There are two said pins (30), which are provided coaxially close to each other to pierce the dome-shaped end of the elongated capsule, and wherein said vortex stir chamber is operated by said pin. 2. The inhaler according to claim 1, further comprising a recess for supporting the elongated capsule. 3. The device according to claim 1, wherein said closing means (22) is movable by pivotally rotating from said first position (22) to said second position (22 '). Or 2 inhalers. 4. The interlock means (38, 46, 48) is responsive to the arrival of the closing means at the first position (22), and wherein the closing member is in the first position. The capsule opening means (30) is free to operate, and the operation of the capsule opening means (30) in any case where the closing means is in any position intermediate to the second position (22 '). The inhaler according to any one of claims 1 to 3, wherein the inhaler is prohibited. 5. The closure member (22) is pivotally movable from the first position to the second position to align the closure member with a stud (38) of the interlock means. Holes (46) for each pair of ears (4
8) so that the stud (38) can move in a direction corresponding to the operation of the capsule opening means until the hole (46) in the ear aligns with the stud (38). 5. The inhaler according to claim 4, wherein the inhaler cannot be used. 6. The lugs (48) are flexible and each comprises a pivoting beso (54) which engages a pivoting recess in the body of the remainder of the inhaler, whereby: By bending the lugs so as to approach or pull away from each other, the lugs are deformed at the time of assembling the inhaler. 6. The inhaler of claim 5 wherein the ear bounces back to a relaxed state to retain the closure member coupled to the rest.